Anastomotic leg arrangement

ABSTRACT

A leg compacting system for compacting inwards a group of legs ( 228 ) of an anastomotic connector towards a central location thereof, comprising, a coupler for coupling to a delivery system on which said connector is mounted; and a plurality of leg confiners ( 820 ), said leg confiners ( 820 ) configured to selectively move in an inwards direction and said confiners configured to have a resting compacted configuration in which a space of between 7 and 1 mm in width is maintained between the innermost leg contacting sections of said confiners such that a graft vessel suitable for mounting on said connector can be passed between said confiners ( 820 ).

RELATED APPLICATIONS

The present application claims priority from and is acontinuation-in-part of PCT application PCT/IL02/00790, filed on Sep.25, 2002, which designates the US, now published in English as WO03/026475. It also claims priority as well as the benefit under 119 (e)of U.S. Ser. No. 60/426,013, filed on Nov. 14, 2002. The disclosure ofboth applications is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to systems and tools used in conjunctionwith anastomotic connectors and/or manipulation of blood vessels.

BACKGROUND OF THE INVENTION

Connecting together of two blood vessels may be performed using ananastomotic connector. In an end-to-side connection, such a connectortypically has a final diameter similar to that of the “end” vessel. Insome connectors, the end vessel is everted over the connector. Anexample of such a connector is shown in Kaster U.S. Pat. No. 5,234,447,the disclosure of which is incorporated herein by reference. Themanipulation of the vessel to be everted may require delicate motorcontrol by the physician and there is a risk of tearing of the vesseldue to its being stretched.

Also, as shown in Kaster, the forward legs are inserted into an aperturein a blood vessel. Such exact insertion may also require delicate motorcontrol and be time consuming and/or difficult.

SUMMARY OF THE INVENTION

A broad aspect of the present invention relates to methods and apparatusfor radially compacting groups of anastomotic legs into a radicallycompact configuration. In an exemplary embodiment of the invention, thegroups of legs are radially compacted prior to eversion, to reduce theeffective diameter of the connector at the leg group, over which a graftvessel is evereted. Optionally, a passage is maintained between the legsfor the passage of a graft vessel, for example a passage of between 1and 3 mm, or a passage of under 4 or 5 mm. Optionally, the group isradially compacted prior to insertion into an aperture in a target bloodvessel.

In an exemplary embodiment of the invention, a leg compacting system isremovably mounted on an anastomosis delivery system. Optionally, thecompacting system has the form of a cap. Alternatively the compactingsystem is integrated with the delivery system, optionally having aminimal profile so as to not interfere with visibility and/or not catchon nearby tissue. Optionally, the compacting system is configured to beoperated using one hand, optionally a hand already holding the deliverysystem.

Optionally, the leg compacting system comprises a leg receptacle foreach leg. Optionally, the receptacles prevent tangling of the legsduring compacting and/or releasing of the legs. Optionally, thereceptacles set relative leg positions for eversion.

In an exemplary embodiment of the invention, the leg compacting systemcomprises a pair of opposing bars which selectively advance towards eachother, trapping and compacting the legs between them. In an alternativeembodiment of the invention, the leg compacting system comprises aplurality of individual leg receptacles, all of which are advanced inconcert.

In an alternative exemplary embodiment of the invention, the legcompacting system comprises a splitable cap. Optionally, the cap issplit using a control on its side.

In an alternative exemplary embodiment of the invention, the legcompacting system comprises a splitable tube which is torn off torelease the legs.

In an alternative exemplary embodiment of the invention, the legcompacting system comprises a lasso-like element (hereafter “lasso”)formed a noose-like loop (hereafter “noose”) at its end which can bereduced in diameter. The compacting system also comprises a receptaclewhich contains the lasso, fits over the legs and assists in capturingthe legs with the lasso. Optionally, a manual controller is provided forselectively and repeatedly releasing and compacting the legs.Optionally, the lasso comprises a single wire folded to form a loop anda tube covering at least a section of the folded wire adjacent the loop.The loop is tightened as a noose by advancing the tube relatively to theloop.

Optionally, the leg compacting system is substantially see-through, forexample, being of open construction or being formed of a transparentmaterial, so that the area of the procedure and/or the connector endsare not hidden from an operator's view.

An aspect of some embodiments of the invention relates to a legarranging device for a noose leg compactor. In an exemplary embodimentof the invention, the leg arranging devices automatically or manuallyreleases a pre-tensioned noose to close around legs of a connector, oncethe legs are properly positioned with respect to the noose.

An aspect of some embodiments of the invention relates to a noosecontroller. Optionally, the controller is stored in a configurationwhich elastically urges the noose to close. Optionally, a lock isprovided to reduce stress on the noose itself. Optionally, the noose iscut at a certain position of the controller.

An aspect of some embodiments of the invention relates to the releaseconfiguration of the legs. In an exemplary embodiment of the invention,the legs are arranged in a generally ellipsoid or circularconfiguration. In some embodiments of the invention, releasing the legsthat are near the ends of the ellipsoid first, stretches the apertureand assists in the other legs engaging blood vessel wall tissue.

An aspect of some embodiments of the invention relates to a method ofmounting a graft into a capsule having an anastomosis connector loadedtherein. In an exemplary embodiment of the invention, the capsule isheld in a cradle, for example a leg compacting cap, and the capsule issplit, so that a graft can be laid inside the capsule. The capsule isthen closed and the graft can be everted on the connector legs. Thecapsule may then be loaded on a delivery system. In an exemplaryembodiment of the invention, the connector comprises a plurality ofclips, for example clips in which long legs are torn of after the longlegs lock to medallions or opposing short legs. In an alternativeembodiment, the connector is a ring connector in which the ring is splitat a location matching the split in the capsule.

An aspect of some embodiments of the invention relates to a deliverysystem with a handle that can be used at various orientations to thesystem. In an exemplary embodiment of the invention, a handle of thedelivery system is selectively rotatable and/or attachable at multiplerotational orientations. Optionally, a tip of the delivery system inwhich a graft is mounted, is rotatable relative to a body of thedelivery system. Optionally, a trigger is used for controlling thedelivery of an anastomosis connector. Optionally, the handle is devoidof controls. Optionally, a pistol grip handle is provided.

An aspect of some embodiments of the invention relates to a step-actiondelivery system in which the delivery system advances and retracts aconnector, in addition to or instead of at least some such motions by auser. In an exemplary embodiment of the invention, the delivery systemseparately provides the actions of advancing the connector tip relativeto the delivery system and tearing of the connector, in which no furtheradvancing is provided. Optionally, a user can deploy an anastomosisconnector without being required to move the delivery system once thelegs are inserted into an aperture in the blood vessel. In an exemplaryembodiment of the invention, the forces required to tear the connectorare provided by releasing a spring, rather than by the user. Optionally,a single control is used for both steps.

An aspect of some embodiments of the invention relates to a anastomoticconnector leg manipulation tool. In an exemplary embodiment, thetransfixion device comprises a handle from which two prongs separated bya fixed distance, extend, thereby forming an aperture between the prongsadapted to at least partially encircle a connector leg. Optionally, eachprong is adapted to pass between adjacent connector legs. In anexemplary embodiment of the invention, the manipulation tool is used toarrange the legs, individually, during compacting. Optionally, the toolis used to arrange the legs during eversion and/or to assist in impalinga graft vessel with a hook portion of a leg and/or to advance an evertedsection. Optionally, the tool is used to push legs into an aperture in ablood vessel, for example, if one or more of the legs pops out duringinsertion and releasing of the legs.

An aspect of some embodiments of the invention relates to using a shuntduring anastomosis. In an exemplary embodiment of the invention, a shuntis inserted into a target vessel through an aperture formed therein foran anastomosis. The shunt prevent blood from flowing near the apertureand shunts it around the anastomosis location so that tissue served bythe blood vessel is not starved. Optionally, the shunt serves to stretchout the blood vessel, so the aperture is not collapsed and is easilyaccessible. In an exemplary embodiment of the invention, the shunt isremoved between legs of the connector, once the connector is properlyplaced.

There is thus provided in accordance with an exemplary embodiment of theinvention, a leg compacting system for compacting inwards a group oflegs of an anastomotic connector towards a central location thereof,comprising:

-   -   a coupler for coupling to a delivery system on which said        connector is mounted; and    -   a plurality of leg confiners, said leg confiners configured to        selectively move in an inwards direction and said confiners        configured to have a resting compacted configuration in which a        space of between 7 and 1 mm in width is maintained between the        innermost leg contacting sections of said confiners such that a        graft vessel suitable for mounting on said connector can be        passed between said confiners. Optionally, said resting        configuration is an innermost configuration. Optionally, said        space is less than 5 mm in width.

In an exemplary embodiment of the invention, said space is oval orcircular.

In an exemplary embodiment of the invention, said system is configuredto be selectively dismounted from said delivery system.

In an exemplary embodiment of the invention, the system comprises acontrol for splitting at least a portion of said system for removal fromsaid delivery system.

In an exemplary embodiment of the invention, said confiners move in aradial direction.

In an exemplary embodiment of the invention, the system comprises arotatable control which selectively moves said confiners in a radialdirection.

In an exemplary embodiment of the invention, said system is permanentlymounted on said delivery system.

In an exemplary embodiment of the invention, each confiner is configuredto receive a single leg.

In an exemplary embodiment of the invention, said plurality of legconfiners are configured to release legs when moved outwards, saidrelease being not simultaneous for all legs.

There is also provided in accordance with an exemplary embodiment of theinvention, a leg compacting system for compacting inwards a group oflegs of an anastomotic connector towards a central location thereof,comprising:

-   -   a coupler for coupling to a delivery system on which said        connector is mounted; and    -   a plurality of leg confiners, said leg confiners configured to        selectively move in an inward direction and said confiners        configured automatically engage said legs as they move inward        inwards. Optionally, wherein each leg confiner is configured to        receive a plurality of legs. Alternatively or additionally, each        leg confiner is configured to receive a single leg.        Alternatively or additionally, said motion is radial.

There is also provided in accordance with an exemplary embodiment of theinvention, a leg compacting system for compacting inwards a group oflegs of an anastomotic connector towards a central location thereof,comprising:

-   -   at least one wire arranged to selectively move inwards, from a        position outwards of the legs, thereby compacting the legs; and    -   a controller which is operative to selectively moving said wire.        Optionally, said wire is adapted to engage said legs near a hook        section of the legs. Alternatively or additionally, the system        comprises at least two wires configured to compact the legs        simultaneously from two directions.

In an exemplary embodiment of the invention, said wire comprises a sidewall adapted to prevent legs from slipping away from compacting.

There is also provided in accordance with an exemplary embodiment of theinvention, a leg arranging device for use with a noose, comprising:

-   -   a body adapted to receive a delivery system on which a plurality        of connector legs are mounted;    -   a noose receptacle arranged around an expected position of said        legs, said receptacle including an inner block which selectively        blocks said noose from leaving said receptacle to engage said        legs; and    -   a control is operative removes said block. Optionally, said        control is automatically activated to release said noose once a        delivery system is inserted in said body and said legs are at        said expected position. Alternatively, said control is manually        activated.

In an exemplary embodiment of the invention, the device comprises anoose controller which pre-stresses said noose to reduce its diameter.

There is also provided in accordance with an exemplary embodiment of theinvention, a leg compacting system for compacting inwards a group oflegs of an anastomotic connector towards a central location thereof,comprising:

-   -   at least one element adapted to compact a plurality of connector        legs to a compacted configuration; and    -   at least controller configured to activate said element thereby        releasing said legs,    -   wherein, said at least one element is configured to release        certain connector legs before other ones of said legs as said        element is activated. Optionally, said element is configured to        first release legs that are on a long axis of an incision into        which said legs are inserted for connection. Alternatively or        additionally, said at least one element defines a plurality of        notches each configured for receiving at least one leg and        wherein an end notch of said at least one element is configured        to release a leg earlier than a leg held by a more central        notch.

There is also provided in accordance with an exemplary embodiment of theinvention, a leg compacting system for compacting inwards a group oflegs of an anastomotic connector towards a central location thereof,comprising:

-   -   a cap adapted to mount on a delivery system, said cap        comprising:        -   at least two sections adapted to form said cap;            -   each of said sections having a front plate defining a                plurality of receptacles for legs; and    -   a control adapted to split said cap into said sections.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of using a noose-type compacting system, comprising:

-   -   mounting a noose on a plurality of connector legs;    -   compacting the legs using the noose;    -   inserting said compacted legs into an aperture in a blood        vessel;    -   releasing and tightening said noose until a desired leg        configuration is achieved; and    -   removing said noose. Optionally, removing said noose comprises        cutting an extension of said noose. Alternatively or        additionally, mounting comprises:    -   arranging said noose around said legs, such that said noose is        pre-stressed; and    -   releasing said noose to engage said legs.

There is also provided in accordance with an exemplary embodiment of theinvention, an anastomosis connector delivery system, comprising:

-   -   a body having an end adapted to mount a connector thereon;    -   a handle adapted to be attached to said body at a plurality of        different orientation positions relative to said body;    -   at least one control for deploying said connector, said handle        being devoid of controls for deploying the connector.        Optionally, said handle is a pistol grip. Alternatively or        additionally, said control is shaped as and moves as a trigger.

There is also provided in accordance with an exemplary embodiment of theinvention, an anastomosis delivery system, comprising:

-   -   a body having a handle section and having a plurality of        connector legs attached to one end thereof;    -   an activation control; and    -   a leg retraction and tearing mechanism,    -   wherein said control both retracts said legs relative to said        body and tears said legs and wherein said control applies said        retracting and said tearing without requiring movement of said        handle by a user. Optionally, said control releases a spring        which provides said tearing. Alternatively or additionally, said        body comprises a moving section and a stationary section, such        that said retraction of said legs moves said moving section        towards said legs and does not move said legs relative to said        stationary section.

In an exemplary embodiment of the invention, the system comprises arecoil absorber which absorbs at least part of a recoil of said springprior to such recoil affecting said handle/

There is also provided in accordance with an exemplary embodiment of theinvention, a sterile anastomosis connector leg manipulator, comprising:

-   -   a handle; and    -   a two pronged extension defining a receptacle between the        prongs, said receptacle being sized to receive one leg of an        anastomosis connector suitable for attaching a vessel of a        diameter smaller than 4 mm, said prongs being thin enough to fit        between adjacent legs of such a connector.

There is also provided in accordance with an exemplary embodiment of theinvention, a leg arranging system for arranging legs of a blood vesselanastomotic connector, comprising:

-   -   a coupler for coupling to a delivery system on which said        connector is mounted;    -   a body; and    -   a plurality of notches defined by said body, each of said notch        configured to hold a single leg. Optionally, said notches        prevent said legs from crossing. Alternatively or additionally,        said notches position said legs in an inwards compacted        configuration.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of mounting a graft, comprising:

-   -   arranging a plurality of connector legs in a leg arranger, such        that their relative positions are fixed in a plane perpendicular        to a general orientation of said legs;    -   providing a graft between said legs; and    -   mounting said graft on said arranged legs. Optionally, said legs        are arranged to have an inward compacted configuration.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of inserting a graft into a blood vessel,comprising:

-   -   arranging a plurality of connector legs in a leg arranger to a        have a desired mutual positional relationship and an inward        compacted configuration; and    -   inserting said arranged legs into an aperture of a blood vessel.

There is also provided in accordance with an exemplary embodiment of theinvention, an anastomotic connector for blood vessels, comprising:

-   -   a ring; and    -   a plurality of legs arranged around said ring, wherein at least        two legs at opposing sides of said ring are configured to bend        radially out more than other of said legs.

There is also provided in accordance with an exemplary embodiment of theinvention, an anastomotic connector for blood vessels, comprising:

-   -   a ring; and    -   a plurality of legs arranged around said ring, wherein at least        two legs at opposing sides of said ring are configured to be        stiffer than other of said legs.

There is also provided in accordance with an exemplary embodiment of theinvention, an anastomotic connector kit, comprising:

-   -   a plurality of leg segments arranged in a generally circular        configuration; and    -   a plurality f leg locking segments, each adapted to be locked to        one leg,    -   wherein, wherein at least two legs at opposing sides of said        circle are configured to be stiffer than other of said legs.

There is also provided in accordance with an exemplary embodiment of theinvention, an anastomotic connector kit, comprising:

-   -   a plurality of leg segments arranged in a generally circular        configuration; and    -   a plurality f leg locking segments, each adapted to be locked to        one leg,    -   wherein, wherein at least two legs at opposing sides of said        circle are configured to bend radially out more than other of        said legs.

There is also provided in accordance with an exemplary embodiment of theinvention, a connector kit, comprising:

-   -   a sterile package    -   a connector having a plurality of forward legs; and    -   a band radially compacting said legs towards a center.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of mounting a graft on a connector delivery systemcapsule, comprising:

-   -   axially splitting said capsule;    -   laying said graft in said capsule;    -   closing said capsule; and    -   mounting said capsule on a connector of said capsule.

There is also provided in accordance with an exemplary embodiment of theinvention, apparatus for mounting a graft on a spoilable graft capsule,comprising:

-   -   a splitable connector capsule;    -   a body including a receptacle large enough to hold a split        capsule and including a slot in its side; and    -   a control which selectable opens said body so said capsule can        open. Optionally, said control actively splits said capsule.        Alternatively or additionally, said body is adapted to radially        compact legs of a connector of said capsule.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of graft attachment to a target vessel, comprising:

-   -   inserting a plurality of legs into an aperture in said target        vessel;    -   releasing at least two of said legs so that said at least two        legs stretch said aperture; and    -   completing said anastomosis. Optionally, said releasing        comprises releasing to ends of an incision.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of graft attachment to a target vessel, comprising:

-   -   inserting a plurality of legs into an aperture in said target        vessel;    -   mechanically retracting said legs relative to a body of a        delivery system; and    -   mechanically tearing said legs,    -   wherein said retracting and said tearing occur without motion of        said legs relative to said vessel.

There is also provided in accordance with an exemplary embodiment of theinvention, a method of performing an anastomosis, comprising:

-   -   forming an opening a target vessel;    -   inserting a shunt into said target vessel to bypass said        opening;    -   inserting a plurality of anastomosis connector legs into said        aperture;    -   removing said shunt between said legs, while said legs are in        said aperture; and    -   completing said anastomosis.

BRIEF DESCRIPTION OF THE FIGURES

Non-limiting embodiments of the invention will be described withreference to the following description of exemplary embodiments, inconjunction with the figures. The figures are generally not shown toscale and any sizes are only meant to be exemplary and not necessarilylimiting. In the figures, identical structures, elements or parts thatappear in more than one figure are preferably labeled with a same orsimilar number in all the Figures in which they appear, in which:

FIGS. 1A and 1B are schematic side views of situations where compactingof legs of an anastomotic device may be useful;

FIGS. 2 and 3 are isometric views of a bar-type leg compacting device,mounted on an anastomotic connector holder, in accordance with anexemplary embodiment of the invention;

FIGS. 4-6 are isometric and schematic views of a splitable legcompacting and arranging cap and its operation, in accordance with anexemplary embodiment of the invention;

FIGS. 7A-7F are top views of an aperture in a blood vessel demonstratingthe positions of anastomotic connector legs as they are selectivelyreleased during connection to the host vessel, in accordance with anexemplary embodiment of the invention;

FIG. 8 is an isometric view of a compacting overtube, in accordance withan exemplary embodiment of the invention;

FIGS. 9-12 are schematic cross-sectional, side and isometric views of aradial leg compacting and arranging device, in accordance with anexemplary embodiments of the invention;

FIG. 13 is an isometric view of a lasso-based leg arranging device andcontroller, in accordance with an exemplary embodiment of the invention;

FIGS. 14A and 14B are side cross-sectional views of a lasso arrangingdevice in two operating states, in accordance with an exemplaryembodiment of the invention;

FIG. 15 is side cross-sectional views of a lasso arranging device with aconnector delivery system mounted therein, in accordance with anexemplary embodiment of the invention;

FIG. 16 is a cross-sectional view of a section of a lasso controller,showing a lasso tearing mechanism, in accordance with an exemplaryembodiment of the invention;

FIG. 17 is a partial cross-sectional view of an alternative embodimentof a lasso arranging system, in accordance with an exemplary embodimentof the invention;

FIG. 18 is a side cross-sectional view of a pistol-grip connectordelivery system, in accordance with an exemplary embodiment of theinvention;

FIG. 19 is an isometric view of the pistol-grip connector deliverysystem of FIG. 18, in accordance with an exemplary embodiment of theinvention;

FIGS. 20A and 20B are isometric views of a leg manipulator, inaccordance with an exemplary embodiment of the invention;

FIG. 21 is a partially cross-sectioned side view of the leg manipulatorof FIGS. 20A and 20B, demonstrating the manipulation of a leg duringeversion, in accordance with an exemplary embodiment of the invention;

FIG. 22 is a side view of the leg manipulator of FIGS. 20A and 20B,demonstrating leg manipulation during insertion of connector legs into atarget vessel, in accordance with an exemplary embodiment of theinvention; and

FIGS. 23A-23E illustrate the use of a shunt, in accordance with anexemplary embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Leg Configuration for Eversion

FIG. 1A shows a graft 140 being mounted on a part of an anastomoticconnector 104. For clarity, the rest of the connector and/or other partsthereof and/or a delivery or holding system are not shown. To completethe mounting, a lip 142 of graft 140 needs to be everted over hooks 220of forward legs 228. In the configuration shown, this requiresstretching lip 142. In exemplary embodiments of the invention, as shownbelow, a leg compacting device is provided to radially compact legs 228,thereby reducing their outer radius and obviating or reducing the needto stretch lip 142.

In some embodiments of the invention, the leg compacting device alsosets relative leg positions for eversion.

Leg Configuration for Insertion

FIG. 1B shows connector 104 being deployed, after a graft 140 is mountedthereon. In the type of anastomotic connection shown, hook ends 220 oflegs 228 need to be inserted into an incision (or aperture) 143 in atarget vessel 144. If incision 143 is made too long, it is easier toinsert hooks 220 into incision 143, however, there is a danger that theanastomosis will not cover all of incision 143 and there may be aleakage of blood. If incision 143 is made smaller, it is more difficultto insert hooks 220 into it. In exemplary embodiments of the invention,as shown below, a leg compacting device brings legs 228 together, asshown in FIG. 1B, so that the outer diameter as measured at hooks 220 issmaller than the diameter of incision 143 and insertion is facilitated.

The devices used for radial leg compacting for eversion may be the sameor different than those used for insertion. In addition, it should benoted that depending on the eversion method and/or delivery system oneor the other of the leg compacting situations may be mooted.

Bar-Type Leg Compacting Device

FIGS. 2 and 3 are isometric views of a bar-type leg compacting device200, mounted on an anastomotic connector holder 100, in accordance withan exemplary embodiment of the invention. Device 200 comprises two bars254 which oppose each other and are positioned so that legs 228 arebetween them. When the bars are brought together, the configuration oflegs 228 is radially compacted. FIG. 2 shows legs 228 compacted by bars254 and FIG. 3 shows legs 228 released from bars 254 and having anatural configuration. Depending on the embodiment, the released legsmay be further apart and/or without a bend in them.

In the embodiment shown in FIGS. 2 and 3, a pair of opposing bars 254radially compact legs 228, near hooks 220, to have a generally linearconfiguration. Compacting near hooks 220 has a potential advantage thatlegs 228 do not cross each other, which may cause undesirableentanglement. Alternatively or additionally, compacting is performed ata point of pre-defined bend in legs 228.

In an exemplary embodiment of the invention, compacting device 200 isused prior to insertion of hooks 220 into a blood vessel bars 254optionally enter the blood vessel, however this is not required in someembodiments. In the configuration of FIG. 2, the hooks are generallyarranged in a line which can be more easily fit into an incision, thanthe spread out configuration of FIG. 3. Alternatively or additionally,device 200 is used during eversion, for example before or after thegraft (not shown) is everted over at least one hook 220.

In the exemplary embodiment shown, bars 254 are smooth, so that legs 228can slip along them. In some cases, such slippage is undesirable androughened bars 254 may be used. Alternatively or additionally, notchesmay be defined in the bars, to receive legs 228. The notches may be, forexample, arranged to correspond to a desired leg arrangement, optionallywith one notch provided per leg. Alternatively, the notches may bearranged so that they engage a leg if the leg slides past a notch.

While bars 254 are shown to be straight, in other embodiments, bars 254may be used to define other configurations of compacted legs. Forexample, bars 254 may define a compressed ellipse, a bent line or bearranged so that the ends of one of bars 254 is curved away from theends of the other bar. Each such arrangement may be suitable forparticular incision shapes and/or to avoid leg entanglement problems,for example. Optionally, device 200, the head of delivery system 100,and/or the whole delivery system, are adapted for rotation to betteralign the legs configuration with the incision (or other aperture) in atarget blood vessel. In embodiments where the connector used is notrotationally symmetric, it may be desirable to maintain a fixedrelationship (or one with limited range of motion) between theorientations of bars 254 and the connector.

While two bars 254 are shown, embodiments with a higher number of barscan be used to obtain more complex configurations, for example threebars can be used to obtain a triangular configuration, with one end thatmay be easier to insert into a blood vessel. Also a single bar can beused, for example, if incomplete compacting is preferred, or if the bargoes past the mid-line axis of delivery system 100, so that it contactsall or most of the legs.

In the embodiments shown, a pair of sides walls 212 is provided witheach bar 254 thus generally defining (from a top view) a rectangle withone wall missing. In some embodiments, as noted below, side walls 212flare out. Optionally, side walls are used to prevent legs 228 fromslipping out from between bars 254. Optionally, the side walls are usedto ensure that even in the open configuration, all the legs areengagable by bars 254. It should be noted that in the embodiment shownbars 254 are slightly recessed from extenders 224 which hold them. Theserecess may also prevent slipping out of legs 228 during compacting. Inan alternative embodiment of the invention, described below, it isdesirable that some of legs 228 be released prior to other ones of thelegs. In an exemplary embodiment of the invention, side walls 212 or therecession of bars 254 is reduced, to allow early release of end legs,which have a pre-defined deformation to bend out in a direction parallelto bars 254.

Optionally, extenders 224 also serve to distance side walls 212 frombars 254. Optionally, side walls 212 can thus serve to herd legs 228 tocorrect alignment with bars 254. Alternatively or additionally, sidewalls 212 are thus placed near a base of legs 228, where for a samedegree of bending of legs 228, there is less spatial motion, so sidewalls 212 can extend out a smaller distance relative to the rest ofdelivery system 100. Optionally, sidewalls 212 angle out (e.g., so thatthe ends further from bars 254 are further apart than the ends attachedto extenders 224), to define a generally cone shape for each one of bars254, to assist in such herding.

As can be appreciated, device 200 could be constructed in various waysto allow selective release and engagement of bars 254. In the particularembodiment shown, each bar 254 and side walls 212 associated with thebar are formed of one continuous wire. In the illustrated embodiment, adistal portion of the wire is formed into a post 210, which ismaintained in a slot 222, formed in device base 226. Slots 222optionally prevent twisting or other misalignment of bars 254. In anexemplary embodiment of the invention, a bend 232 is formed in the wire,so that if the wire is pulled back, contact of more distal, parts of thewire with base 226 will cause the wire to pull away from base 226.

In an exemplary embodiment of the invention, a bar controller 230 isprovided which is coupled to posts 210 and is selectively locatable atmultiple axial location relative to delivery system 100. Retraction ofcontroller 230, will retract the wire and cause bars 254 to open. Inthis case, bars 254 move in a direction including both axial andtrans-axial components. In an alternative embodiment, a distal portion234 of the wire is curved away from the more proximal portions, so thatif the wire is pulled back over a rim of base 226 or through one or moreholes defined in it and having a diameter greater than at a proximalportion of slots 222, bars 254 are moved apart. Other methods may beused as well. For example, the wires may act as levers with a part ofbase 226 serving as a pivot. Pushing the wires together on one side ofthe pivot, for example by sliding a restraining controller 230 overthem, will move the other ends of the wires apart.

Optionally, bars 254 are configured to prevent over compacting. Forexample, extenders 224 may block each other when they meet.Alternatively, bars 254 may be aligned so that they block each otherfrom further motion once they contact, and the degree of compacting islimited by the degree of recessing of bars 254 relative to extenders224.

It should be noted that a device similar to device 200 may beconstructed from plastic, for example as a solid, rather than as wires,for some embodiments of the invention. However, wires typically have theadvantage of being visually unobtrusive.

Splitting Cap Compacting Device

FIGS. 4 and 5A are isometric and schematic views of a splitable legcompacting and arranging cap 800 and its operation, in accordance withan exemplary embodiment of the invention. Cap 800 comprises a body 802which terminates in leg holding lips 808 and 810. In an exemplaryembodiment of the invention, cap 800 is adapted to be split so that lips808 and 810 move apart, releasing legs to an expanded configuration. Inan exemplary embodiment of the invention, body 802 is formed of twohalves 820 and a handle 841, which can be manipulated to selectivelysplit cap 800. Optionally, cap 800 can also be selectively closed, tocompact legs 228.

In an exemplary embodiment of the invention, halves 820 are adapted tobe mounted on delivery system, 100, for example by an internal ridge 806engaging a matching slot or ridge in delivery system 100. Other mountingmethods can be used. When body 802 is split, halves 820 move indirections 840, thereby releasing arranging cap 800 from delivery system100. In an exemplary embodiment of the invention, halves 820 define attheir proximal ends cone shaped sections 814 and 816, which terminate atlips 808 and 810. Optionally, each of lips 808 and 810 defines aplurality of notches 822, each of which notch can hold one of legs 228.

In an exemplary embodiment of the invention, handle 841 includes apush-button 842, however, other control types can be used. When button842 is pushed in a direction 846, halves 820 move apart in directions840. Conversely, when button 842 is released, halves 820 move indirections 830, to close. Button 842 and the splitting action areoptionally spring loaded, for example so body 820 remains normallyunsplit.

Various splitting mechanism may be used for splitting apart cap 800. Inone example, each of halves 820 includes an extension 852 that fitsinside handle 841. These extensions are crossed, like scissors. Thus,advancing button 842, forces the extensions apart and the cap splits. Inan alternative embodiment, pins or projections 844 serve as hinges forextensions 852 which do not cross, and splitting is achieved by button842 engaging a rounded section 854 of extensions 852, on their outside(e.g., with an arc section), so that extensions 852 move together,thereby splitting cap 800.

While cap 800 is shown to be pre-split along its entire length, this isnot the case in all embodiments. For example, the cap my be a singlepiece adapted to split along the slit shown, under stress. Alternativelyor additionally, the split area between body 802 and handle 841 is notcompletely split and serves as a hinge. It should be noted thatdepending on the location of the pivot point for the splitting and thesplitting mechanism used, halves 820 can move apart in various ways,including different angles being formed between the halves andsubstantially parallel separation of halves 820. The type of relativemotion of the halves may be an issue in embodiments as described below,where a selective release of legs from either side of the cap is desiredto be synchronized in a certain manner. In some embodiments, cap 800 canbe opened and closed several times. In other, opening damages the cap soreclosing is not feasible.

In an exemplary embodiment of the invention, cap 800 is providedpre-mounted on delivery system 100 and is used during eversion andreleased only after insertion into the body. Alternatively, cap 800 maybe release before insertion and optionally a different compacting methodused for insertion. Alternatively or additionally, cap 800 may bemounted by a physician, for example before or after eversion. In thiscase, a forceps may be used to guide legs 228 into notches 822.Optionally, a leg manipulation tool, for example as described below, isused to guide or move legs 228.

Optionally, cap 800 is used to assess the size of the graft being used.When cap 800 is split, legs 228 expand outwards until the radius of thegraft is reached. At this point, further expansion is reduced orprevent. By slowly splitting cap 800, the radius of the graft can beassessed. Optionally, suitable markings are provided on handle 841,possibly with through holes for viewing the position of extensions 852.This method of graft measurement may also be used in other legcompacting and releasing embodiments described herein. Optionally, suchgraft measurement is used to assess if a correct connector and/or graftvessel are being used and/or to help in determining a size of incisionto make in a target vessel.

In an exemplary embodiment of the invention, the connector used is amedallion type connector, for example as described in WO 03/026475, thedisclosure of which is incorporated herein by reference. In such aconnector, each leg has an associated medallion which may migrate alongthe leg. In an exemplary embodiment of the invention, lips 808 and 810prevent the medallions from passing by them along legs 228.

A potential benefit of arranging legs in this and other embodiments isfor correct eversion. Another potential advantage is for inserting intoa blood vessel, where arranging of the legs can serve to ensure a properspacing between the legs. As described below, a leg manipulator may beused to move legs if they re not correctly positioned.

Split Graft Capsule

FIG. 5B illustrates another use of a splitable cap 800, which may beinstead or in addition to leg arrangement. In ring-type connectors, agraft is passed through a side of the delivery system, through anopening in the ring of the connector and out between the legs. This pathmay require using a special snare. In an exemplary embodiment of theinvention, it is noted that a connector may include a split in the ringor may be formed of a plurality of individual clip-like elements thatact together when deployed as a single connector. In an exemplaryembodiment of the invention, a capsule 1160 is splitable on either side,lengthwise. Cap 800 holds the capsule and when it is split, using knob842 (not visible) capsule 1160 is split as well. In the embodimentillustrated, capsule 1160 is actively split. For example, an extension864 of control 842 may terminate with an non-circular end 866, which isplaced in a far (relative to picture plane) slot 872 of capsule 1160.When control 842 is rotated and end 866 apply forces to sides 868 and870 of slot 872, forcing capsule 1160 open, optionally thereby alsoopening cap 800. Optionally, capsule 1160 does not fall apart, as cap800 is holding it. The graft can then be placed in a slot 1180 and thencapsule 1160 is closed. Optionally, once mounted on the delivery system,the delivery system prevents the capsule from splitting. In analternative embodiment, capsule 1160 is provided split and thenassembled around the graft, without cap 800. Alternatively to cap 800,other capsule opening and/or restraining devices may be used, includingfor example, a rubber band to keep capsule 1160 in one piece while beingopened by hand or with forceps.

A reference 862 shows an approximate mounting location for the connectorsegments.

Leg Arranging Notches

FIG. 6 is a top view of lips 808 and 810, showing the position ofnotches 822, in accordance with an exemplary embodiment of the inventionand also showing optional special notches 838 and end legs 238, whichwill be described below. These lips may be used for arranging legs, forexample prior to eversion and/or prior to insertion.

Leg Release Arrangement

FIGS. 7A-7F are top views of an aperture in a blood vessel demonstratingthe positions of anastomotic connector legs as they are selectivelyreleased during connection to the host vessel, in accordance with anexemplary embodiment of the invention.

FIG. 7A shows an aperture 143 formed in a target vessel 144. FIG. 7Bshows the positions of legs 228 as inserted into the aperture 143. Theinventors have found that in some cases the lips of aperture 143 areflaccid and hooks 220 do not all engage lip tissue and/or engage it at apoint too close or too far away from the actual edge of the aperture. Inan exemplary embodiment of the invention, the connector legs are used tostretch aperture 143 so that its lips are tighter and there is bettercontrol over the points where hooks 220 engage. It should be noted thataperture 143, when made by incision is typically thinner. An exemplaryincision maker is described in a PCT application filed on same date asthis application in the Israel receiving office of the PCT, by a sameapplicant “By-Pass Inc.”, having the title “BLOOD VESSEL CUTTER” andhaving attorney docket number 088/03505, the disclosure of which isincorporated herein by reference.

FIG. 7C shows an embodiment where one (or more) end legs 238 eachengages an opposite end of aperture 143 and stretches it. In oneembodiment of the invention, the legs of the connector are pre-stressedto achieve a layout as shown in FIG. 7C. Alternatively, thisconfiguration is achieved by selective release of legs and/or bypositioning of legs using a leg compacting device.

FIG. 6 shows how special notches 838 can be defined which release legs238 early, before legs can escape notches 822. Optionally, the notchesare positioned so that the legs touch near hooks 220 when held by thenotches in a closed position of cap 800. While notches 838 are shown tobe symmetrical, if the splitting of cap 800 is around a pivot, anasymmetrical design may be useful for embodiments where substantiallysimultaneous release of legs at opposing sides is desired.Alternatively, an intentional earlier release of one of legs 838 beforethe other one of legs 238, is practiced.

FIG. 7D shows the further stretching of aperture 143 by legs 238, atwhich point legs 228 may be released and then retracted. Optionally, theleg compacting device is provided with a tactile feedback so that a usercan feel when the device has reached a second position, so the user canpause after releasing legs 238 and before releasing legs 228. In anexemplary embodiment of the invention, an incision is between 2 mm and3.5 mm prior to stretching and is stretched to between 3 and 4.5 mm or 5mm.

FIG. 7E shows the final position of hooks 220.

FIG. 7F shows the resulting connection profile after the delivery systemis removed, in which the natural elasticity of the vessel and/or designof the connector shapes the final profile. It should be noted that agreater or smaller number of legs may be used than the 8 shown,depending, for example, on the size of the connection. This method mayalso be used for non-linear and non-circular holes. In particular, threelegs 238 may be used for dealing with a triangular aperture. Inaddition, the positioning of legs 238 may depend not only on the shapeand orientation of aperture 143 but also on the graft vessel, forexample, it may be desirable to have legs 238 positioned at the pointsof greatest and smallest angle between the graft and target vessels.

It should be noted in this and other embodiments, that the connectorneed not be formed of one continuous piece, especially after deployment.For example, the connector may be a set of staples that are deliveredtogether and are possibly attached during deployment.

Leg Release Design

Alternatively or additionally to providing cap which releases legs 228and 238 in a desired order, in an exemplary embodiment of the invention,the connector is pre-configured such that the end legs extend radiallymore than the inner legs. Alternatively or additionally, the deliverysystem aims the legs (e.g., by angling the apertures and/or medallionswhere they exit the delivery system) more to the sides. Thus, FIG. 7Bshows the legs when confined by a noose. FIG. 7C shows partial releaseand FIG. 7D shows complete release. Closing the anastomosis allows thegraft vessel to affect the configuration so FIGS. 7E and then 7F areachieved.

In a ring type or two part connector, the connector or the legs partscan be configured to provided extended and/or stronger radial motion foronly some of the legs. In multi-part connectors that comprise aplurality of unconnected legs, the side legs may be selected to be morebent our and/or stronger. In an exemplary embodiment of the invention,the legs used to stretch the incision are two legs from either side ofthe connection (e.g., when arranged along the incision as in FIG. 7B).In one example the two upper right legs extend to the right and the twobottom left legs extend to the left.

Tear Over-Tube

FIG. 8 is an isometric view of a compacting overtube 2000, in accordancewith an exemplary embodiment of the invention. Overtube 2000 is anelongate tube-like object having a diameter suitable for a desired legcompacting geometry. Optional, tube 2000 defines a plurality of slots2020 in its interior, each of the slots adapted to engage a singleconnector leg 228.

In an exemplary embodiment of the invention, overtube 2000 has a uniformdiameter. Alternatively, tube 2000 is tapering, on its inside at least,for example to conform to a cone shape of legs 228.

In an exemplary embodiment of the invention, a notch 2010 or otherweakening of over tube 2000 is provided along the over tube. In anexemplary embodiment of the invention, overtube 2000 is removed bytearing or cutting at the notch, as described below.

Optionally, overtube 2000 is made of a material which can be heat-shrunkonto the legs and/or delivery system.

In an exemplary embodiment of the invention, each notch 2020 holds oneleg 228 and hooks 220 are outside of overtube 2000, for example, curvedover a front face 2040 of the overtube. Optionally, slots (not shown)are formed in face 2040, to receive hooks 220. Alternatively, hooks 220are straightened by overtube 2000. Alternatively or additionally, hooks220 are received in notches 2020, further compressing legs 228 together.If heat-shrunk, the shrinking can be uneven on the legs and/or thedelivery system.

In an exemplary embodiment of the invention, notch 2010 is torn using atear tab 2002. In one example, tab 2002 comprises a wire that runs alongnotch 2010 (e.g., is embedded therein) and extends out as visible tab2002. Pulling on tab 2002, tears the notch. In another example, thebottom of notch 2010 includes two parallel slits, and tab 2002 isattached to the material between the two slits. Alternatively, a knifeis used to cut notch 2010, for example, manually, or a knife mounted onthe delivery stream. Alternatively, delivery system 100 is splitable andas it splits, the delivery system also splits apart overtube 2000.Alternatively, a cone shape object having a larger base diameter thanovertube 2000 is advanced over legs 228, from the direction of deliverysystem 1000, splitting overtube 2000.

In an exemplary embodiment of the invention, overtube 2000 is providedmounted on legs 228, when delivery system 100 is packaged. A snare,described for example in a PCT application titled “SNARE”, filed by asame applicant “By-Pass inc.” in the Israel receiving office of the PCTon same date as this application, and having attorney docket number088/03612, the disclosure of which is incorporated herein by reference,is optionally used to convey a graft through delivery system 100. Slightretraction of overtube 2000 may reveal hooks 220 and allow the graftvessel to be everted over them. Optionally, overtube 2000 is cut afterhooks 220 are inserted into a target vessel.

In an alternative use, legs 228 are inserted, hooks first, into overtube2000, which is then optionally cut to form a short ring.

Radial Leg Compacting

FIGS. 9-12 are schematic cross-sectional, side and isometric views of aradial leg compacting and arranging device 1600, in accordance with anexemplary embodiment of the invention.

FIGS. 9 and 10 are side cross-sectional view of device 1600, shownmounted on a delivery system 100. While not shown, an optional lockingmechanism is provided, to prevent inadvertent axial motion of device1600. For example, a slot and pin arrangement or a friction arrangementmay be used for preventing axial motion.

FIG. 9 shows device 1600 is a resting position (for a normallyclosed-type device; normally open devices are also possible), in whicheach of legs 228 is engaged by a finger 1610. Optionally, fingers 1610are extensions of a body 1612, which fingers are maintained pointedradially inwards by an outer sleeve 1640. A spring 1642 is optionallyprovided to maintain outer sleeve 1640 in its resting position.

In FIG. 10, sleeve 1640 is retracted, allowing fingers 1610 to spreadout, releasing legs 228. As shown, graft 140 is mounted in theconfiguration of FIG. 9 and after eversion is completed, legs 228 arereleased.

FIG. 11 is a side view of a variation of device 1600, in which sleeve1640 is controlled by a rotating ring 1680, whose rotation advances andretracts sleeve 1640. Alternatively or additionally, the rotationadvances and retracts fingers 1610.

FIG. 12 is an isometric view of device 1600 mounted on delivery system100. It should be noted that fingers 1610 are shown to form a completering, when compressed together. Alternatively, they do not touch.Optionally, a notch 1614 is defined at the end of each finger 1610, toact as a receptacle for a leg 228.

Optionally, a plurality of markers are formed along fingers 1610, atlocations 1616 (FIG. 10). If sleeve 1640 is retracted slowly, legs 228stop expanding at the point where the inner radius defined by fingers1610 is approximately equal to the radius of the graft. The markingsindicate the radius of the graft.

In an exemplary embodiment of the invention, device 1600 is provided ona packaged delivery system 100. Alternatively, it may be added after thefact by a user.

Lasso System

FIG. 13 is an isometric view of a lasso-based leg arranging device andcontroller system 600, in accordance with an exemplary embodiment of theinvention. A lasso noose 615 (not shown) is used to compact legs 228. Toassist in mounting noose 615 on legs 228, a leg arranging device 602 isprovided, which allows a noose to close only once legs 228 are properlypositioned with respect to noose 615. In an exemplary embodiment of theinvention, a controller 606 is provided for selectively tightening andreleasing noose 615 and, optionally, for tearing the lasso.

Controller 604 comprises a body 606 and a plunger 610, although otherdesigns are possible. In an exemplary embodiment of the invention,controller 606 contains an internal spring (not shown) configured topush out plunger 610. Noose 615 optionally comprise a wire 642 (notshown) or string folded in half (the folded area defining a noosesection) and optionally covered by a protective tube 614. Tube 614 isattached to body 606, while the wire is attached to plunger 610. Thus,outward motion of plunger 610, will tend to pull the wire into the tubeto tighten the noose. Optionally plunger 610 is locked to body 606, forexample, to prevent forces on noose 615 during storage. In an exemplaryembodiment of the invention, body 606 contains one or more handles 608which also have a geometry suitable for holding arranging device 602. Inan exemplary embodiment of the invention, a recess 612 is defined in anextension of plunger 610, such that arranging device 602, when placed inhandle 608, locks plunger 610.

Optionally arranging device 602 is provided pre-loaded with noose 615.Protective tube 614 is shown entering a slot 616 formed in side ofarranging device 602, for this purpose and for receiving a graft vessel.

FIGS. 14A and 14B are side cross-sectional views of noose arrangingdevice 602 in two operating states, in accordance with an exemplaryembodiment of the invention, in which noose section 615 of the lasso isshown, but tube 614 is not.

Arranging device 602 comprises a body 620 with an inner sleeve 622, bothof which open to an opening 623. When a delivery system is inserted intoopening 623, sleeve 622 is pressed up, with results as described below.Attached to and inside body 620 is a noose holding ring 624 whichincludes an inner receptacle 626 for holding noose 615. Ring 624 ispositioned adjacent where legs 228 are expected to reach when a deliverysystem is inserted into opening 623. Noose 615 is, however, preventedfrom closing on legs 228, by an inner cage 628 which has a plurality ofextensions 630 locking noose 615 inside receptacle 626. A solid designfor the cage may be used as well. A spring 632 optionally urges cage 628to be in a closed state. Alternatively, friction is used to preventinadvertent motion of cage 628.

FIG. 14A shows cage 628 in its closed state. FIG. 14B shows cage 628 inits open state, caused by sleeve 622 moving cage 628 against spring 632.Noose 615 is shown released, but not yet tightened, for clarity.

FIG. 15 shows arranging device 602 with a delivery system 100 insertedinside. Delivery system 100 and/or arranging device are adapted to pushsleeve 622 by a required amount so that noose 615 will be release at acorrect axial position of legs 228. Once noose 615 is released, plunger610 will pull out and the user can remove delivery system 100 fromarranging device 602. Optionally, noose 615 is released adjacent a pointon legs 228 other than its final position. However, due to its beingtensed and legs 628 being compacted into a cone shape, noose 615 canslide to a final resting position, and further tightening.

At this point, legs 228 are compacted and a graft can be everted on thelegs or the legs can be inserted into a blood vessel.

A particular feature of controller 604 in some embodiments of theinvention, is that by manipulating plunger 610, the noose 615 of thelasso can be selectively tightened and released. For example, afterinsertion into a blood vessel aperture, if releasing the legs does notresult in a correct leg placement, the noose can be tightened (with thelegs being compacted) and a new attempt made. Optionally, controller 604can be mounted on delivery system 100. Alternatively or additionally,tube 614 is long enough to allow controller 604 to lie comfortablyoutside the patients body.

FIG. 16 is a cross-sectional view of a section of a lasso controller,showing a lasso tearing mechanism 640, in accordance with an exemplaryembodiment of the invention. Once the use of noose 615 is completed,noose 615 is optionally removed by tearing the lasso wire (642). FIG. 16shows one possible tearing mechanism, in which protective tube 614 iscoupled to a metal tube 644 having an inclined edge 648 and plunger 610is coupled to a second metal tube 464, having an inclined edge 650. Wire642 lies within the tubes. When plunger 610 is pushed in all the way,inclined surfaces 648 and 650 contact and then slip by each other, forexample, only tube 646 having non-axial motion. The inclined surfacesact as scissors to shear-cut wire 642. Wire 646 is thus detached fromthe controller and can be removed from the anastomosis area buy pullingon one end thereof. In an alternative embodiment, rotation of plunger610 relative to body 606 tears the wires. Alternatively, other tearingmechanism, including a hand-held scalpel, may be used. In someembodiments of the invention, wire 642 is only cut at one location, sothat it remains attached to controller 604 at all times.

FIG. 17 is a partial cross-sectional view of an alternative embodimentof a lasso arranging system 700, in accordance with an exemplaryembodiment of the invention. The reference numbers generally correspondto the reference numbers of FIGS. 13-15 and will not be described again.One possible alteration is in the design of a controller 704, in whichlocking is achieved by a pin 712 engaging a notch 711, in a body 706 ofcontroller 704. Rotation of a handle 710 releases pin 712 from thenotch. Another possible alteration is that instead of automatic releaseof noose 615 when delivery system 100 is completely inserted, a button740 is depressed to move a cage 728 out of the way, against an optionalspring 732.

While noose 615 has been generally described as being used forcompacting legs prior to insertion, it should be noted that it can alsobe used for an aid for eversion. In an exemplary embodiment of theinvention, controller 600 has two retracting positions for plunger 610.One in which the legs are completely compacted together, without leavinga space and one in which a space to pass a graft is provided.

In an alternative use of a leg arranging and/or compacting device, anend-to-end connection of two vessels is supported. The lasso or otherleg compactor is used to compact the legs of a connector mounted on afirst vessel. The compacted legs are inserted into an end of a secondvessel. The lips of the second vessel are mounted on the hooks and thenthe legs are release. Possibly, the legs are released prior to mounting,until the legs reach the diameter of the other vessel. After mounting onthe other vessel, the connection is completed, for example, by pullingand tearing in a medallion type connector.

Pistol Grip Delivery System

FIG. 18 is a side cross-sectional view of a pistol-grip connectordelivery system 1100, in accordance with an exemplary embodiment of theinvention. FIG. 19 is an isometric view of pistol-grip connectordelivery system 1100. Delivery system 1100 is used to show two features,which are not necessarily both present. A first feature is a pistol grip1110, which can be optionally attachable at multiple orientations, forexample as can be seen by comparing FIG. 18 and FIG. 19, where the gripis rotated 180 degrees. Other optional features which may assist ingripping and using of delivery system 1100, are a roughed area 1184 anda trigger 1170 used to activate delivery system 1100.

A second feature of delivery system 1100 which may be providedalternatively or additionally to the pistol like features is acontrolled deployment of connector 104, in which a user is not requiredto move the delivery system and/or in which power for tearing isprovided by a spring released by a user, rather than directly by theuser.

System 1100 comprises a body 1120 on which pistol grip 1110 is attached,for example using a snap attachment 1182. In an exemplary embodiment ofthe invention, snap attachment 1182 allows positioning and/or attachingof grip 1110 at multiple positions, for example, 2, 6, 8, 10 or asmaller, intermediate or larger number of positions, for example, every20, 30 or 45 degrees. A trigger 1170 is configured, in this embodimentto pivot, and follow a path 1186. A safety pin 1112 is optionallyprovided to prevent motion of the trigger unless also pressed in a smallamount.

In an exemplary embodiment of the invention, system 1100 operates in twostages. In a first stage, trigger 1170 directly moves hooks 220 relativeto a tip 1160. In the example shown, tip 1160 is advanced, while legs228 do not move. Alternatively, legs 228 can be retracted, while tip1160 remains in place. In either case, optionally, a user is notrequired to move body 1120 relative to the patient. A potentialadvantage of not actually moving legs 228 is that retraction of the legsmay cause them to tear tissue and/or distort.

In a second stage, a spring 1134 is released to tear legs 228 off of thedelivery system, again optionally without moving body 1120. In anexemplary embodiment of the invention, the following mechanism is used.Connector 104 is attached to a piston 1178, by a coupler 1162, whichpiston is coupled to a compressed spring 1134. However, a plate 1177lies in a notch 1122 of piston 1178 and the other end of spring 1134 topiston 1178. In the embodiment shown, a ring 1176, which is optionallyfixed to body 1120 also serves as a base for spring 1134, and which ringrests against plate 1177. In an exemplary embodiment of the invention,plate 1177 is part of a rectangular element 1116 with an aperture 1118which is larger than a cross-section of piston 1178 and through whichpiston 1178 fits. A spring 1114 urges element 1116 in a direction whichwould release plate 1177 from notch 1122, however, an extension 1174prevents this motion. Extension 1174 is optionally coupled to a tube1180 on which a barrel 1164 and tip 1160 are mounted. The first stageadvances tube 1180, and also extension 1174. Sufficient advancementclears the path for plate 1177, which is urged to unlock piston 1178 byspring 1114. Spring 1134 expands, pulling back connector 104, while tip1160 does not move, thereby tearing off legs 228 and completing theanastomosis. Optionally, plate 1177 in its unlocking position preventsextension 1174 and thus tip 1160 from retracting under the force ofspring 1134. Alternatively or additionally, one or more pins 1190 popout once they are advanced with tube 1180 past the edge of body 1120.Once they pop out, tube 1180 can no longer be retracted. Alternativelyor additionally, an extension 1175 of trigger 1170 locks tube 1180 tobody 1120. In an exemplary embodiment of the invention, an extension1173 of a body 1172 of trigger 1170 is what advances tube 1180 trigger

In an alternative mechanism, trigger 1170 itself moves plate 1177 out ofthe way, for example using a pin (not shown) on extension 1175.

Optionally, a sponge 1188 or an oil cylinder is provided to slow theexpansion of spring 1134, thereby preventing delivery system 1100 fromjumping. Alternatively or additionally, sponge 1188 does not slow downthe spring opening. Instead, it serves to reduce a recoil effect whenthe spring hits body 120. Reducing recoil may prevent the user frommoving handle 1110.

Alternatively, a battery powered motor may be used for the tearing. Itshould be noted that an exemplary force required to tear legs 228 isabout 25 Kg. However, the triggering mechanism allows the user to applya small force, and, optionally, not be subject to jumping of deviceand/or not be required to move the device.

Optionally, a safety (not shown) is provided which prevents trigger 1170from activating spring 1134 if a capsule with a connector is not placedinto barrel 1180.

Legs 228 may be compacted using the methods described above.Alternatively, for this and other types of delivery systems, the legsmay be pre-stressed to be bent inwards. This helps eversion. Once agraft is mounted on the legs, the graft tends to pull the legs apart, soa lasso or other mechanism is used for compacting. It should be notedthat in this case the legs may be shorter and/or the delivery system isnot required to selectively advance and retract the legs.

In an alternative solution, also useful for multiple types of deliverysystems, the connector legs are pre-stressed to bend out or be straight.A band, for example a ring of silicon, or a string is provide don theconnector in the packaging, to compact the legs. After eversion, thisband is cut, and removed. optionally, a string is attached to the band,to prevent it from getting lost after removal.

Leg Manipulator

FIGS. 20A and 20B are isometric views of a leg manipulator 1800, inaccordance with an exemplary embodiment of the invention. Manipulator1800 comprises a handle 1820 having an optional taper section 1812 fromwhich a tip 1810 extends, optionally at an angle. Alternatively oradditionally, section 1812 may be at an angle to shaft 1820. In anexemplary embodiment of the invention, tip 1810 comprises twin prongs1860 and 1870, which optionally meet at a curved section 1880. Thus, tip1810 defines a leg receptacle 1844, which is adapted for partiallyencircling an anastomotic connector leg 228. In an exemplary embodimentof the invention, prongs 1860 and 1870 are in on plane and extend abouttwo or three times the width of a leg 228. For example, a leg may have awidth of between 0.2 and 0.35 mm and a thickness of between 0.1 and 0.2mm. As will be described below, manipulator 1800 is used for movingindividual legs 228. Optionally, prongs 1860 and 1870 are made thinenough so that a leg can be manipulated without affecting nearby legs.

FIG. 21 is a partially cross-section side view of a delivery system 1100showing leg manipulator 1800 assisting in eversion and/or movement of agraft 140 over a leg 228. In one example, manipulator 1800 is used as aneversion assistance device, such as shown in WO 03/026475, thedisclosure of which is incorporated herein by reference, for example inFIG. 6. Alternatively, for example with reference to FIG. 4, manipulator1800 can be used prior to eversion, for example to arrange the legs orto assist in compacting, for example by pushing legs to individualnotches 822, if they do not align correctly by themselves. Alternativelyor additionally, manipulator 1800 is used to untangle leg tangles.

FIG. 22 is a side view of leg manipulator 1800, demonstrating legmanipulation during insertion of legs 228 into an aperture 143 of targetvessel 144, in accordance with an exemplary embodiment of the invention.when legs 228 are released or if other insertion methods are used, oneor more of legs 228 may pop out of aperture 143. Manipulator 1800 isoptionally used to push such legs 228 back into aperture 143.Alternatively or additionally, manipulator 1800 is used to arrange legs228 and especially hooks 220 in a desired alignment with respect toaperture 143. Alternatively or additionally, manipulator 1800 is used toassist a hook 220 in piercing the wall of target vessel 140.

Leg Manipulator Specifications

In an exemplary embodiment, receptacle 1844 may be 0.65 millimeters indiameter (e.g., width), for example when hook 220 has a diameter of 0.6millimeters. Alternatively or additionally, receptacle 1844 may be aslarge as 0.70 millimeters or larger or as small as 0.61 millimeters orsmaller. Hook 220 may have a larger diameter, for example when used inanastomosis of large vessels, the size of receptacle 1844 will beappropriately changed.

In an exemplary embodiment, each prong 1860 and 1870 of tip 1810 issized to fit between two adjacent connector legs 228 and may have across-section side-to-side size of 0.45 millimeters, when the spacebetween legs 228 is, for example 0.40 millimeters. Alternatively oradditionally, prongs 1860 and/or 1870 may have a sided-to-side size aslarge as 0.50 or more millimeters or as small as 0.41 millimeters orless.

In an exemplary embodiment, receptacle 1844 is shown with “U” shape1880, in which prongs 1860 and 1870 are parallel to each other andspaced apart. In other exemplary embodiments, prongs 1860 and 1870 maybe angled to each other and/or there may be a V shaped meeting.Alternatively or additionally, the prongs may lie on different planesfrom each other and/or different from neck 1812. The shapes of legs 228may for example, influence the difference in shape.

Shunt

FIGS. 23A-23E illustrate the use of a shunt 2000, in accordance with anexemplary embodiment of the invention. In some embodiments of theinvention, the anastomosis process may take more than a few seconds, forexample one minute, two minutes or more. During this time, aperture 143may be open. In some cases, it is not practical to stop the flow ofblood in target vessel 144, especially if it is a single coronaryartery.

Shunt 2002 can be a standard shunt used to bypass from one side ofaperture 143 to the other. For example, the shunt can be formed of anelastic material, such as silicone and have a first side 2002 includingan entrance (not shown) and being capable of expanding to a diametergreater than that of the coronary artery, and a second side 2004 withthe same properties. An opening 2008 in the middle of the shuntcorresponds to the anastomosis area and is bordered by one or more shuntblood passages 2006. An optional removal thread 2010 can be used to pullthe shunt out of the blood vessel when the anastomosis is nearcompletion.

FIG. 23A shows shunt 2002 before insertion into target vessel 144through aperture 143.

FIG. 23B shows the shunt inserted and also shows how sides 2002 and 2004expand to greater than the vessel diameter, to reduce flow frombypassing the shunt. Removal thread 2010 is visible.

FIG. 22C shows a delivery system being used, with legs 228 being held bya lasso 615.

FIG. 22D shows the lasso having been removed after legs 228 werepositioned in a desirable manner. At this point, hooks 220 areoptionally retracted so that they engage the wall of vessel 144.Optionally, one of hooks 220 is moved out of the way, for example, usingmanipulator 1800, to allow room for the shunt between two adjacent legs228.

FIG. 22E shows shunt 2000 being removed by pulling on removal thread2010. In an exemplary embodiment of the invention, hooks 220 holdaperture 143 to prevent its tearing by the pulling. In some cases,removal of the shunt requires that legs 228 be able to move apart. Onepossibility is if legs 228 are long, for example having more than 10,15, 20 or 30 mm free space between the vessel and the delivery system.Another possibility is if the connector is of a type where the legs eachlock to a separate element and the legs are optionally not attached toeach other. in this case, the graft, on which the legs are mountedallows for some freedom of motion between the legs, so the shunt can beremoved.

An alternative use of the ability of the legs to move is for aside-to-side connection, in which one side vessel is placed between thelegs in a trans-axial direction. A protective sheet may be provided toprevent the sides of legs 228 from cutting into the side vessel. In anexemplary embodiment of the invention, the delivery system is split togo on either side of the connection, optionally with a ring providedbetween the two vessel during the procedure to keep the connection to acorrect shape.

Application

The above leg arranging and graft manipulation methods and/or devicesmay be used with many types of delivery systems. In particular, thefollowing documents, the disclosures of which are incorporated herein byreference describe connectors, delivery systems and/or other tools andmethods which are useful in conjunction with embodiments of the preventinvention:

-   -   PCT/IL02/00790, filed on Sep. 25, 2002, now published as WO        03/026475;    -   U.S. Ser. No. 60/492,998 filed on Aug. 7, 2003.    -   PCT/IL02/00215, filed on Mar. 18, 2002, now published as WO        02/074188;    -   PCT/IL01/01019, filed on Nov. 4, 2001, now published as WO        02/47532;    -   PCT/IL01/00903, filed on Sep. 25, 2001 now published as WO        02/30172;    -   PCT/IL01/00600, filed on Jun. 28, 2001, now published as WO        02/47561;    -   PCT/IL01/00267, filed on Mar. 20, 2001, now published as WO        01/70091;    -   PCT/IL01/00266, filed on Mar. 20, 2001, now published as WO        01/70090;    -   PCT/IL01/00074, filed on Jan. 25, 2001, now published as WO        01/70119;    -   PCT/IL01/00069, filed on Jan. 24, 2001, now published as WO        01/70118;    -   PCT/IL00/00611, filed on Sep. 28, 2000, now published as WO        01/41624;    -   PCT/IL00/00609, filed on Sep. 28, 2000, now published as WO        01/41623,    -   PCT/IL00/00310, filed on Mar. 20, 2000, now published as WO        00/56228;    -   PCT/IB00/00302, filed on Mar. 20, 2000, now published as WO        00/56227;    -   PCT/IL99/00674, filed on Dec. 9, 1999, now published as WO        00/56223;    -   PCT/IL99/00670, filed on Dec. 8, 1999, now published as WO        00/56226;    -   PCT/IL99/00285, filed on May 30, 1999, now published as WO        99/62408; and    -   PCT/IL99/00284, filed on May 30, 1999, now published as WO        99/62415. The disclosure of all of these applications, which        designate the US and were filed in English, are incorporated        herein by reference.

In addition, two PCT applications filed on same date with the presentapplication, by applicant “By-Pass inc.”, and describing anastomoticconnectors are, “Sliding Surgical Clip” and “Anastomotic connectors”,attorney docket numbers 088/03506 and 088/03736, the disclosures ofwhich are incorporated herein by reference. A provisional applicationfiled on even date with the instant application, by applicant Loshakoveet al., and having attorney docket number 088/03695 is also incorporatedherein by reference and describes an exemplary delivery system.

It should be noted that the term “connector” should be construed broadlyto include various types of connectors, including one part, two part andmultiple part connectors, some of which when deployed, result in aplurality of individual clip-like sections.

The term “eversion”, where used means not only complete eversion of 180degrees, but also partial eversion or flaring, for example of 90degrees. Also, in some embodiments, mounting without eversion isprovided.

Measurements are provided to serve only as exemplary measurements forparticular cases. For example, 2.5 millimeter diameter of a connector101 and the size of the aperture 143 may apply to a connector that isconnected to a LIMA, while connectors 101 and/or apertures 143 that areused in conjunction with other vessels, for example a vein, may havealternative sizes. Even when used in, for example the LIMA, the exactmeasurements stated in the text may vary depending on the application,the type of vessel (e.g., artery, vein, xenograft, synthetic graft),size of connector, shape of hole (e.g., incision, round) and/or sizes ofvessels involved (e.g., 1 mm, 2 mm, 3 mm, 5 mm, aorta sized).

In some embodiments, one or more of the devices, generally sterilize,described above, are packaged and/or sold with an instruction leaflet,describing the device dimensions and/or situations for which the deviceshould be applied. Also within the scope of the invention are surgicalkits comprising sets of medical devices suitable for making anastomoticconnections.

It should be appreciated that the above may be varied and still fallwithin the scope of the invention, for example, by changing the order ofsteps or by providing embodiments which include features from severaldescribed embodiments or by omitting features described herein. Sectionheadings where are provided are intended for aiding navigation andshould not be construed to limiting the description to the headings.

When used in the following claims, the terms “comprises”, “comprising”,“includes”, “including” or the like means “including but not limitedto”.

It will be appreciated by a person skilled in the art that the presentinvention is not limited by what has thus far been described. Rather,the scope of the present invention is limited only by the followingclaims.

1. A leg compacting system for compacting inwards a group of legs of ananastomotic connector towards a central location thereof, comprising: acoupler for coupling to a delivery system on which said connector ismounted; and a plurality of leg confiners, said leg confiners configuredto selectively move in an inwards direction and said confinersconfigured to have a resting compacted configuration in which a space ofbetween 7 and 1 mm in width is maintained between the innermost legcontacting sections of said confiners such that a graft vessel suitablefor mounting on said connector can be passed between said confiners. 2.A system according to claim 1, wherein said resting configuration is aninnermost configuration.
 3. A system according to claim 1, wherein saidspace is less than 5 mm in width.
 4. A system according to claim 1,wherein said space is oval or circular.
 5. A leg compacting systemaccording to claim 1, configured to be selectively dismounted from saiddelivery system.
 6. A leg compacting system according to claim 1,comprising a control for splitting at least a portion of said system forremoval from said delivery system.
 7. A leg compacting system accordingto claim 1, wherein said confiners move in a radial direction.
 8. A legcompacting system according to claim 1, comprising a rotatable controlwhich selectively moves said confiners in a radial direction.
 9. A legcompacting system according to claim 1, wherein said system ispermanently mounted on said delivery system.
 10. A leg comprising systemaccording to claim 1, wherein each confiner is configured to receive asingle leg.
 11. A leg comprising system according to claim 1, whereinsaid plurality of leg confiners are configured to release legs whenmoved outwards, said release being not simultaneous for all legs.
 12. Aleg compacting system for impacting inwards a group of legs of ananastomotic connector towards a central location thereof, comprising: acoupler for coupling to a delivery system on which said connector ismounted; and a plurality of leg confiners, configured to selectivelymove in an inward direction and to automatically engage said legs whilemoving inwards.
 13. A leg compacting system according to claim 12,wherein each leg confiner is configured to receive a plurality of legs.14. A leg compacting system according to claim 12, wherein each legconfiner is configured to receive a single leg.
 15. A leg compacting sysaccording to claim 12, wherein said motion is radial.
 16. A legcompacting system for compacting inwards a group of legs of ananastomotic connector towards a central location thereof, comprising: atleast one wire arranged to selectively move inwards, from a positionoutwards of the legs, thereby compacting the legs; and a controllerwhich is operative to selectively moving said wire.
 17. A leg compactingsystem according to claim 16, wherein said wire is adapted to engagesaid legs near a hook section of the legs.
 18. A leg compacting systemaccording to claim 16, comprising at least two wires configured tocompact the legs from two directions.
 19. A leg compacting systemaccording to claim 16, wherein said wire comprises a side wall adaptedto prevent legs from slipping away from compacting.
 20. A leg arrangingdevice for use with a noose, comprising: a body adapted to receive adelivery system on which a plurality of connector legs are mounted; anoose receptacle arranged around an expected position of said legs, saidreceptacle including an inner block which selectively blocks said noosefrom leaving said receptacle to engage said legs; and a control isoperative removes said block.
 21. A device according to claim 20,wherein said control is automatically activated to release said nooseonce a delivery system is inserted in said body and said legs are atsaid expected position.
 22. A device according to claim 20, wherein saidcontrol is manually activated.
 23. A device according to claim 20,comprising a noose controller which pre-stresses said noose to reduceits diameter.
 24. A leg compacting system for compacting inwards a groupof legs of an anastomotic connector towards a central location thereof,comprising: at least one element adapted to compact a plurality ofconnector legs to a compacted configuration; and at least controllerconfigured to activate said element thereby releasing said legs,wherein, said at least one element is configured to release certainconnector legs before other ones of said legs as said element isactivated.
 25. A system according to claim 24, wherein said element isconfigured to first release legs that are on a long axis of an incisioninto which said legs are inserted for connection.
 26. A system accordingto claim 24, wherein said at least one element defines a plurality ofnotches each configured for receiving at least one leg and wherein anend notch of said at least one element is configured to release a legearlier than a leg held by a more central notch.
 27. A leg compactingsystem for compacting inwards a group of legs of an anastomoticconnector towards a central location thereof, comprising: a cap adaptedto mount on a delivery system, said cap comprising: at least twosections adapted to form said cap; each of said sections having a frontplate defining a plurality of receptacles for legs; and a controladapted to split said cap into said sections.
 28. A method of using anoose-type compacting system, comprising: mounting a noose on aplurality of connector legs; compacting the legs using the noose;inserting said compacted legs into an aperture in a blood vessel;releasing and tightening said noose until a desired leg configuration isachieved; and removing said noose.
 29. A method according to claim 28,wherein removing said noose comprises cutting an extension of saidnoose.
 30. A method according to claim 28, wherein mounting comprises:arranging said noose around said legs, such that said noose ispre-stressed; and releasing said noose to engage said legs.
 31. Ananastomosis connector delivery system, comprising: a body having an endadapted to mount a connector thereon; a handle adapted to be attached tosaid body at a plurality of different orientation positions relative tosaid body; at least one control for deploying said connector, saidhandle being devoid of controls for deploying the connector.
 32. Asystem according to claim 31, wherein said handle is a pistol grip. 33.A system according to claim 31, wherein said control is shaped as andmoves as a trigger.
 34. An anastomosis delivery system, comprising: abody having a handle section and having a plurality of connector legsattached to one end thereof; an activation control; and a leg retractionand tearing mechanism, wherein said control both retracts said legsrelative to said body and tears said legs and wherein said controlapplies said retracting and said tearing without requiring movement ofsaid handle by a user.
 35. A delivery system according to claim 34,wherein said control releases a spring which provides said tearing. 36.A delivery system according to claim 34, wherein said body comprises amoving section and a stationary section, such that said retraction ofsaid legs moves said moving section towards said legs and does not movesaid legs relative to said stationary section.
 37. A delivery systemaccording to claim 35, comprising a recoil absorber which absorbs atleast part of a recoil of said spring prior to such recoil affectingsaid handle/
 38. A sterile anastomosis connector leg manipulator,comprising: a handle; and a two pronged extension defining a receptaclebetween the prongs, said receptacle being sized to receive one leg of ananastomosis connector suitable for attaching a vessel of a diametersmaller than 4 mm, said prongs being thin enough to fit between adjacentlegs of such a connector.
 39. A leg arranging system for arranging legsof a blood vessel anastomotic connector, comprising: a coupler forcoupling to a delivery system on which said connector is mounted; abody; and a plurality of notches defined by said body, each of saidnotch configured to hold a single leg.
 40. A leg arranging systemaccording to claim 39, wherein said notches prevent said legs fromcrossing.
 41. A leg arranging system according to claim 39, wherein saidnotches position said legs in an inwards compacted configuration.
 42. Amethod of mounting a graft, comprising: arranging a plurality ofconnector legs in a leg arranger, such that their relative positions arefixed in a plane perpendicular to a general orientation of said legs;providing a graft between said legs; and mounting said graft on saidarranged legs.
 43. A method according to claim 42, wherein said legs arearranged to have an inward compacted configuration.
 44. A method ofinserting a graft into a blood vessel, comprising: arranging a pluralityof connector legs in a leg arranger to a have a desired mutualpositional relationship and an inward compacted configuration; andinserting said arranged legs into an aperture of a blood vessel.
 45. Ananastomotic connector for blood vessels, comprising: a ring; and aplurality of legs arranged around said ring, wherein at least two legsat opposing sides of said ring are configured to bend radially out morethan other of said legs.
 46. An anastomotic connector for blood vessels,comprising: a ring; and a plurality of legs arranged around said ring,wherein at least two legs at opposing sides of said ring are configuredto be stiffer than other of said legs.
 47. An anastomotic connector kit,comprising: a plurality of leg segments arranged in a generally circularconfiguration; and a plurality f leg locking segments, each adapted tobe locked to one leg, wherein, wherein at least two legs at opposingsides of said circle are configured to be stiffer than other of saidlegs.
 48. An anastomotic connector kit, comprising: a plurality of legsegments arranged in a generally circular configuration; and a pluralityf leg locking segments, adapted to be locked to one leg, wherein,wherein at least two legs at opposing sides of said circle areconfigured to bend radially out more than other of said legs.
 49. Aconnector kit, comprising a sterile package; a connector having aplurality of forward legs; and a band radially comprising said legstowards a center, within the sterile package.
 50. A method of mounting agraft on a connector delivery system capsule, comprising: axiallysplitting said capsule; laying said graft in said capsule; closing saidcapsule; and mounting said capsule on a connector of said capsule. 51.Apparatus for mounting a graft on a spoilable graft capsule, comprising:a splitable connector capsule; a body including a receptacle largeenough to hold a split capsule and including a slot in its side; and acontrol which selectable opens said body so said capsule can open. 52.Apparatus according to claim 51, wherein said control actively splitssaid capsule.
 53. Apparatus according to claim 51, wherein said body isadapted to radially compact legs of a connector of said capsule.
 54. Amethod of graft attachment to a target vessel, comprising: inserting aplurality of legs into an aperture in said target vessel; releasing atleast two of said legs so that said at least two legs stretch saidaperture; and completing said anastomosis.
 55. A method according toclaim 54, wherein said releasing comprises releasing to ends of anincision.
 56. A method of graft attachment to a target vessel,comprising: inserting a plurality of legs into an aperture in saidtarget vessel; mechanically retracting said legs relative to a body of adelivery system; and mechanically tearing said legs, wherein saidretracting and said tearing occur without motion of said legs relativeto said vessel.
 57. A method of performing an anastomosis, comprising:forming an opening a target vessel; inserting a shunt into said targetvessel to bypass said opening; inserting a plurality of anastomosisconnector legs into said aperture; removing said shunt between saidlegs, while said legs are in said aperture; and completing saidanastomosis.